FDA 510(k) Application Details - K120782

Device Classification Name	More FDA Info for this Device
510(K) Number	K120782
Device Name	INTERVENTIONAL HEMOSTATIC BANDAGE
Applicant	Z-MEDICA CORPORATION 4 FAIRFIELD BLVD. WALLINGFORD, CT 06492 US Other 510(k) Applications for this Company
Contact	SHEILA WALLIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2012
Decision Date	03/20/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review